Sarepta and Roche Seek to Resume Elevidys Trials After EMA Halt
The European Medicines Agency (EMA) may lift the temporary hold on certain Phase III studies...
Drug
Bayer’s Vividion Therapeutics Starts Phase I Study for RAS-PI3Kα Inhibitor
German pharmaceutical giant Bayer’s (ETR: BAYN) wholly owned subsidiary Vividion Therapeutics, Inc. has announced the...
Fujian Kerui’s Generic Sirolimus Gel Approved by China’s NMPA
China-based Fujian Kerui Pharmaceutical Co., Ltd. announced that its generic version of Pfizer’s (NYSE: PFE)...
Henlius Biotech’s HLX04-O Shows Positive Results in wAMD Phase III Trial
China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced positive results from the Phase III...
Mabwell Bioscience’s 7MW3711 ADC Receives Clinical Trial Approval in China
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that it has received clinical trial...
Novartis’ Vanrafia Gets FDA Accelerated Approval for IgAN
Switzerland-based Novartis (NYSE: NVS) announced that it has received accelerated approval from the US Food...
Shionogi Partners with Link Medical for Cefiderocol Development in Australia and New Zealand
Japan-based Shionogi Co., Ltd. has entered into an exclusive licensing agreement with Link Medical Products...
Guojian Qingke Biomedical Gains NMPA Approval for 3D MSCs in Stroke Trials
China-based Guojian Qingke Biomedical Technology (Beijing) Co., Ltd. announced that it has received tacit clinical...
Gan & Lee Pharmaceuticals Secures Pakistan Approval for Insulin Glargine Cartridge
Gan & Lee Pharmaceuticals (SHA: 603087) has announced the receipt of marketing approval for its...
Biogen’s BIIB080 Receives FDA Fast Track Designation for Alzheimer’s
US-based Biogen Inc. (NASDAQ: BIIB) announced that it has received Fast Track designation (FTD) from...
Novartis’ Fabhalta Approved in China for C3 Glomerulopathy
Novartis’ (NYSE: NVS) Fabhalta (iptacopan) has received approval from China’s National Medical Products Administration (NMPA)...
Shionogi Submits Rolling NDA for Ensitrelvir in US for COVID-19 Prophylaxis
Shionogi announced on April 1, 2025, the initiation of a rolling New Drug Application (NDA)...
Pfizer Expands Abrysvo RSV Vaccine Indication to Include Ages 18-59 in EU
Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has amended the marketing...
AccurEdit’s ARTbase-A1 Base Editor Authorized by USPTO
On April 2, 2025, China-based AccurEdit Therapeutics (Suzhou) Co., Ltd., a specialist in gene editing...
Zhifei Bio’s Trivalent Influenza Vaccine Approved for Clinical Trials in China
Zhifei Biological (SHE: 300122) announced on April 1, 2025, that its subsidiary Zhifei Longcom has...
Henlius and Organon’s HLX11 Biosimilar Clears EMA Validation Hurdle
Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon (NYSE: OGN) announced that the European Medicines...
Huadong Medicine’s Semaglutide Injection Accepted for Review by China’s NMPA
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that the National Medical Products Administration (NMPA)...
Hengrui Pharmaceuticals Secures Clinical Trial Approval for HRS-9813 in IPF
Hengrui Pharmaceuticals (SHA: 600276) announced on April 1, 2025, that its HRS-9813 capsule has received...
Luye Pharma’s Weekly Rivastigmine Patch Approved in Japan for Alzheimer’s
China-based Luye Pharma Group (HKG: 2186) announced that it has received marketing approval from Japan’s...
BeiGene’s Tevimbra Recommended for EU Approval in Small Cell Lung Cancer
BeiGene, Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), the China-based oncology specialist proposing to rename...